Two Approaches, One Goal: Comparing EU And UK Exposure Assessments

Exposure assessment plays a crucial role in risk assessment for regulated products, including novel foods, food additives, and food enzymes. These assessments combine nationally representative food consumption data with the intended use levels of the ingredient under review.

To ensure public safety, Regulatory Authorities apply conservative methods, typically evaluating high-level (95th percentile) exposure estimates to safeguard even the most vulnerable populations.

With recent updates to EFSA’s novel food guidance, exposure assessments within the European Union (EU) now require the use of validated models such as the Food Additive Intake Model (FAIM) or the Dietary Exposure (Diet Ex) tool. Similarly, the UK Food Standards Agency (FSA) continues to follow comparable methodologies post-Brexit, using the EFSA Comprehensive Food Consumption Database or the UK National Diet and Nutrition Survey (NDNS).

This article by Maven Regulatory Solutions explores the key methodological differences between the EU and UK exposure assessment frameworks and their impact on regulatory submissions.

EU Exposure Assessment Approach

The European Food Safety Authority (EFSA) maintains the Comprehensive Food Consumption Database, which forms the foundation for exposure assessments across 29 European countries. Updated in December 2024, this database supports the FAIM and Diet Ex tools, both used to estimate dietary exposure for novel food, food additive, and enzyme applications.

Key Characteristics

• Data Source: Surveys from 22 EU Member States.
• Age Coverage: Infants, toddlers, children, adolescents, adults, and elderly populations.
• Data Variability: Diverse methodologies (e.g., 24-h recall vs 48-h recall, 2- or 3-day diaries).
• Food Categorization: Organized using FoodEx2, a harmonized EU food classification system.

Although the database provides broad coverage, variability across countries often leads to wider exposure ranges. The 95th percentile values generated are typically conservative, aligning with EFSA’s risk-based approach to ensure consumer protection across all demographics.

UK Exposure Assessment Approach

The UK National Diet and Nutrition Survey (NDNS) serve as the primary data source for exposure assessments in the United Kingdom. Funded by the UK government, NDNS monitors food consumption, nutrient intake, and nutritional status across the population.

Key Features

• Survey Design: Continuous rolling survey using a 4-day consecutive food diary.
• Coverage: Individuals aged 1.5 years and older.
• Data Period: Most recent data include Years 9–11 (2016–2019) with 3,558 participants.
• Data Quality: Statistically robust and representative of UK dietary habits.
• Additional Metrics: Biomarker collection, physical measurements (height, weight, blood pressure).

NDNS provides granular food-coding data and high differentiation between similar food types, enabling more precise dietary exposure modeling. Its consistent data-collection methodology makes it a valuable resource for specific UK exposure assessments.

Case Study: Comparing EU vs UK Exposure Estimates

A fictional novel food ingredient was assessed using both EFSA’s Comprehensive Database (via Diet Ex) and UK NDNS data to estimate adult intake levels.

The 12-gram difference observed between the EU and UK 95th percentile intakes demonstrate how methodological and dietary differences influence exposure outcomes.

In practice, using NDNS-based exposure estimates for UK novel food applications may permit broader food categories or higher maximum use levels, provided that overall safety margins remain within established limits.

Regulatory Implications

For EU applications, exposure assessments must rely on the EFSA Comprehensive Database. Currently, the UK FSA accepts both EFSA and NDNS-based assessments, but this dual acceptance may change as UK regulations evolve.

Because EFSA’s model integrates data from multiple countries with diverse dietary patterns, it often yields higher exposure estimates compared with UK NDNS, which represents a single national dataset.

Sponsors should therefore consider:

• Regulatory expectations (EU vs UK)
• Data precision vs conservatism
• Impact on ingredient approval and use levels

Future regulatory divergence between the EU and UK may lead to distinct exposure assessment requirements, necessitating region-specific data for each jurisdiction.

Expert Guidance from Maven Regulatory Solutions

At Maven Regulatory Solutions, we specialize in Regulatory Affairs, Toxicology Support, and Exposure Assessment Consulting for:

• Novel Food Applications (EU & UK)
• Food Additives and Enzymes
• Dietary Intake Modeling and Risk Assessment
• CTD Dossier Preparation and Submission Strategy

Our experts leverage the latest FAIM, Diet Ex, and NDNS datasets to build scientifically sound and compliant exposure assessments tailored to both EU and UK regulatory requirements.

Contact our team to discuss your ingredient’s optimal exposure assessment pathway and streamline your regulatory submissions with confidence.